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March 18, 2026Molecules0 citationsOpen Access

Development and Validation of SEC-UV/HRMS Procedure for Simultaneous Determination of BSA and Its Association Products

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BHB. HodnikŽČŽiga ČamičMPMatevž Pompe

Key Points

  • This research aims to develop a method to simultaneously analyze BSA monomers and oligomers using SEC-UV/HRMS.
  • Developed SEC-UV/HRMS method optimized for native-like analysis.
  • Used electrospray ionization for efficient ionization of proteins.
  • Evaluated mobile-phase composition and chromatographic conditions for enhanced sensitivity.
  • Employed short, narrow-bore UHPLC SEC separation column with low-flow rates for effective results.
  • Implemented a 60 °C stress-testing protocol to monitor oligomerization dynamics.
  • Detected BSA monomers and oligomers up to heptamer size.
  • Achieved acceptable linearity, precision, and sample stability.
  • Revealed transient oligomer species undetectable by UV methods alone.
  • Confirmed molecular-weight trends through comparative analysis with SEC-RALS/LALS.

Abstract

Monitoring peptide and protein self-association is essential for understanding biological function, formulation stability, and aggregation mechanisms. While size-exclusion chromatography (SEC) is routinely used to quantify protein-size variants under native conditions, its hyphenation to high-resolution mass spectrometry (HRMS) for simultaneous structural characterization remains limited. Here, we report the development and validation of a robust SEC-UV/HRMS method optimized for native-like analysis of bovine serum albumin (BSA) monomers and higher-order oligomers using standard-flow electrospray ionization. Systematic evaluation of source parameters, mobile-phase composition, and chromatographic conditions enabled retention of native BSA structure, minimized in-source unfolding, and enhanced MS sensitivity, allowing detection of oligomers up to the heptamer. A short, narrow-bore 200 Å UHPLC SEC separation column was used. Low-flow separations (~0.05 mL/min) enabled efficient ionization and 10 min run times. An accelerated 60 °C stress-testing protocol demonstrated that SEC-MS can semi-quantitatively monitor oligomerization dynamics, complementing UV-based quantification and revealing transient species not resolved by UV alone. The method showed acceptable linearity, precision, and sample stability, and comparison with SEC-RALS/LALS confirmed molecular-weight trends across aggregation states. Overall, the developed SEC-UV/HRMS workflow provides a rapid, sensitive, and widely accessible approach for UV-based quantification of monomer- and HRMS-based characterizing protein aggregation in research and quality control in pharmaceutical laboratories.

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Cite This Study

Hodnik et al. (2026) studied this question.

synapsesocial.com/papers/69ba43e94e9516ffd37a5916https://doi.org/10.3390/molecules31061001
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